EUCTR2008-000227-25-DE进行中（未招募）不适用
A single-center, single-blind, randomized, oral dose cross-over study in prepuberal boys with ADHD to investigate efficacy and bioequivalence of 20 mg Ritalin LA® compared to 20 mg Medikinet® retard after treatment with o.d. doses over 7 days each.
Dept. Child & Adolescent Psychiatrie0 个研究点开始时间: 2008年3月6日最近更新:
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相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •Patients who meet all of the following inclusion criteria will be eligible for enrollment in the study:
- •1.Male patients aged 8-14 with Tanner stages 0 to 2 and a BMI between the 10th and 90th age percentile
- •2.Patients having a diagnosis of ADHD of any type according to DSM-IV criteria, as established by history, psychiatric examination and a structured diagnostic interview (Kiddie-Sads-Present and Lifetime Version; see Appendix 3)
- •3.Patients, whose symptoms are adequately controlled by a stable and well-tolerated dose of a immediate release methylphenidate equivalent of 20 mg to 30 mg for one month before screening.
- •4.Patients with parents or a legal guardian, who will give written informed consent for the child to participate in the study. Additionally, assent to participate must be obtained from all children entering the study if the child is able to judge the nature, the meaning and the significance of the clinical trial (according to §40 Abs. 4 No. 4 AMG). Assent will be documented by the child’s signature on the consent form.
- •5.Health status: Patients must have no clinically significant diseases or clinically significant abnormal laboratory values as assessed during medical history and physical exam.
- •6.Patients meeting minimum intelligence requirements: In the opinion of the investigator the patient must generally be functioning at age-appropriate levels academically, which should take into account any prior cognitive or academic testing(basic knowledge of reading, writing and calculating).
- •7.Patients already receiving behavioral therapies for HKS/ADHD may continue to do so during the course of the trial.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion Criteria:
- •1.Patients with comorbid psychiatric conditions with symptoms requiring current pharmacological treatment (e.g. major depression, psychosis).
- •2.Patients with comorbid psychiatric or somatic conditions that may contraindicate treatment or confound efficacy or safety assessments.
- •3.Patients who are taking any concomitant medications likely to interfere with the study drug or confound efficacy or safety assessments, e.g.
- •Tricyclic antidepressants, SSRIs except Fluoxetine, bupropion, clonidine, buspirone 2 weeks before randomization.
- •Atomoxetine 2 weeks before randomization.
- •Fluoxetine or antipsychotics 1 month before randomization.
- •Pemoline and amphetamines 1 week before randomization.
- •4.Patients with a known non-response to methylphenidate.
- •5.History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures.
- •6.Patients who are judged by the investigator as likely to be non-compliant with study procedures, including those with a suspected history of substance abuse, or patients living with a person diagnosed with a substance abuse disorder.
- •7.Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
- •8.Patients with warnings, mentioned in the German Basic Prescribing Information of Ritalin LA® (Fachinformation, November 2002): anorexia, severe depression, anxiety disorder, Gilles de la Tourette-Syndrome, other tic disorder, hypertension, occlusive arterial diseases, severe stenocardia, tachycardiac arrhythmia, stroke, hyperthyroidism, increased intra-ocular pressure, hypertrophy of the prostate, known hypersensitivity to sympathomimetics, MAO-inhibitors.
- •9.Patients with a history of seizure disorder.
- •10.History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
研究者
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